The US Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above.

Gilead Sciences, Inc. GILD obtained FDA approval for its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, for the prevention of HIV. The regulatory body approved lenacapavir, under the ...

Pfizer's Hympavzi showed superior bleed control in hemophilia A and B patients with inhibitors, reducing bleeding rates and showing good tolerability.

(Reuters) -The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for ...

The FDA expanded the approval of Moderna’s RSV vaccine, extending the license to include more adults and giving the company a welcome win.

The Food and Drug Administration has approved an updated label for Amyvid (florbetapir F 18 injection) to support Alzheimer disease diagnosis in patients.

Successful trial data in a subset of hemophilia patients has set up Pfizer’s Hympavzi, which was approved eight months ago, for a label expansion ...

The Food and Drug Administration has approved Moderna's new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus.

The FDA has approved a new, twice-yearly PrEP injection from pharmaceutical giant Gilead. The drug is lenacapavir. The twice-yearly formulation has the brand name Yeztugo.

Bayer has scored an FDA label expansion for Nubeqa, which now can be used by all patients with metastatic castration-resistant prostate cancer.

The FDA has already approved various c-MET-targeted drugs, including small-molecule multiple receptor tyrosine kinase inhibitors like Exelixis’s cabozantinib (Cabometyx, Cometriq) and Pfizer’s ...

The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the ...